Chronic DiseaseAPPROVALSNCT02883322
Adaptation Process of Patient-Reported Outcomes, an eVALuation Study
An observational study of Chronic Disease, run by GUILLEMIN Francis, MD.
Trial summary
Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process : Four translations of a questionnaire will be produced: A simple translation by two translators… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Cross cultural adaptation of patient reported outcomes (PRO)
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a chronic condition, susceptible to answer the adapted questionnaire
Who may be able to join
- Adult (other 18 years)
- Able to read, understand and answer the adapted questionnaire
- Having a medical condition targeted by the questionnaire
Who cannot join
None listed.
About this study
Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process :
Four translations of a questionnaire will be produced:
- A simple translation by two translators, who serves as the basis for the three other translations
- A translation made with the use of a back-translation.
- A translation with review by an expert committee.
- A translation the use of a back-translation and review by an expert committee.
Properties of each translation will be analyzed and compared
- Conditions
- Chronic Disease
- Being tested
- Cross cultural adaptation of patient reported outcomes (PRO)
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross cultural adaptation of patient reported outcomes (PRO)Other
Process used to adapt a questionnaire from one cultural setting to another
| Study group | Role | What they receive |
|---|---|---|
| Initial | Patients answering the initial translation Receives: Other: Cross cultural adaptation of patient reported outcomes (PRO) | |
| Committee-only | Patients answering the translation modified by an expert committee Receives: Other: Cross cultural adaptation of patient reported outcomes (PRO) | |
| BT-only | Patients answering the translation modified with the use of a back-translation Receives: Other: Cross cultural adaptation of patient reported outcomes (PRO) | |
| Both | Patients answering the translation modified by an expert committee with the use of a back-translation Receives: Other: Cross cultural adaptation of patient reported outcomes (PRO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
heiQ questionnaire
Face/content validity, reliability, structural validity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startDec 2010
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- GUILLEMIN Francis, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie, Région Lorraine
- Responsible party
- Sponsor-investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
- Investigators
- Francis Guillemin, MD, PHD, Study director, Inserm, CHRU Nancy, Université de Lorraine, CIC 1433 Épidémiologie Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883322
- Sponsor's protocol ID
- APPROVALS
- Acronym
- APPROVALS
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17.
PubMed 25698408Epstein J, Osborne RH, Elsworth GR, Beaton DE, Guillemin F. Cross-cultural adaptation of the Health Education Impact Questionnaire: experimental study showed expert committee, not back-translation, added value. J Clin Epidemiol. 2015 Apr;68(4):360-9. doi: 10.1016/j.jclinepi.2013.07.013. Epub 2013 Sep 29.
PubMed 24084448
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation Process of Patient-Reported Outcomes, an eVALuation Study
- ClinicalTrials.gov ID
- NCT02883322
- Acronym / sponsor ID
- APPROVALS / APPROVALS
- Conditions
- Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- GUILLEMIN Francis, MDUniversity, hospital or other
- Collaborators
- Societe Francaise de Rhumatologie, Région Lorraine
- Study start
- Dec 2010
- Primary completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process :
Four translations of a questionnaire will be produced:
- A simple translation by two translators, who serves as the basis for the three other translations
- A translation made with the use of a back-translation.
- A translation with review by an expert committee.
- A translation the use of a back-translation and review by an expert committee.
Properties of each translation will be analyzed and compared
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Initial | – | Other: Cross cultural adaptation of patient reported outcomes (PRO)Patients answering the initial translation |
| Committee-only | – | Other: Cross cultural adaptation of patient reported outcomes (PRO)Patients answering the translation modified by an expert committee |
| BT-only | – | Other: Cross cultural adaptation of patient reported outcomes (PRO)Patients answering the translation modified with the use of a back-translation |
| Both | – | Other: Cross cultural adaptation of patient reported outcomes (PRO)Patients answering the translation modified by an expert committee with the use of a back-translation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a chronic condition, susceptible to answer the adapted questionnaire
Key inclusion criteria (3 listed)
- Adult (other 18 years)
- Able to read, understand and answer the adapted questionnaire
- Having a medical condition targeted by the questionnaire
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross cultural adaptation of patient reported outcomes (PRO)Process used to adapt a questionnaire from one cultural setting to another | Other | BT-only, Both, Committee-only, Initial |
Primary outcome
heiQ questionnaire
Time frame: baseline
Face/content validity, reliability, structural validity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Background: PubMed 25698408Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17.
- Results publication: PubMed 24084448Epstein J, Osborne RH, Elsworth GR, Beaton DE, Guillemin F. Cross-cultural adaptation of the Health Education Impact Questionnaire: experimental study showed expert committee, not back-translation, added value. J Clin Epidemiol. 2015 Apr;68(4):360-9. doi: 10.1016/j.jclinepi.2013.07.013. Epub 2013 Sep 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis Guillemin, MD, PHD study director
Inserm, CHRU Nancy, Université de Lorraine, CIC 1433 Épidémiologie Clinique
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by GUILLEMIN Francis, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heiQ questionnaire (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02883322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.